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FDA Globalization

In today's world, other countries produce significant portions of the food and medical products that U.S. consumers and patients use in their daily lives. In fact, 136,400 foreign facilities in more than 150 countries export FDA-regulated products to the United States. U.S. imports include:

  • Approximately 10 to 15 percent of the U.S. food supply;
  • 53 percent of fresh fruits, 29 percent of vegetables, and 93 percent of seafood consumed in the U.S. and,
  • About 35 percent of the medical devices used in the U.S.

FDA faces ever-greater challenges in determining whether a product has been properly manufactured, distributed and stored and even in determining who has handled the product.  The manufacture of a single product can now involve multiple parties from different countries that are engaged at various steps throughout the process. Along the way, there are opportunities for the product to be improperly formulated or packaged, contaminated, diverted, counterfeited or adulterated.

FDA has mobilized diverse approaches as part of its strategy to address the complex issues posed by globalization, including efforts to:

  • develop new enforcement and regulatory tools
  • conduct more foreign inspections
  • increase collaboration with foreign regulators and other stakeholders
  • develop internationally-harmonized standards and standards convergence
  • educate foreign industry about FDA requirements, and
  • increase transparency and accountability in the supply chain

Responsibility for addressing these global issues is distributed across the agency. The Office of Regulatory Affairs conducts inspections and reviews imported products offered for entry into the United States. FDA’s product centers focus on international policy and outreach that touches on their portfolio of regulated products and the Office of Global Policy and Strategy serves as a focal point for FDA-wide coordination and information sharing and a point of access to multilateral organizations like the World Health Organization; addresses issues related to international trade of regulated products and mutual recognition agreements; enters into arrangements that facilitate the sharing of information with global regulatory counterparts; and manages FDA’s foreign offices around the world.

For more information:

Beginning in 2008, FDA established foreign offices, posting staff in strategic locations around the world, including China, Europe, India and Latin America.  FDA offices overseas work closely with foreign governments, industry, and other stakeholders to enable FDA to more effectively protect U.S. consumers. 

Globalization Contacts

Office of Global Policy and Strategy
10903 New Hampshire Avenue
Building 1
Silver Spring, MD 20993

FDA_Global@fda.hhs.gov

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